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Europe: Euro Convergence 2024: From AI to supply chain management

2024/05/10  RAPS

This year’s Euro Convergence conference focuses on the theme of “regulatory collaboration through unification” as regulatory professionals across Europe come together to learn about challenges and potential solutions related to supply chains, artificial intelligence (AI), and the implications of IVDR implementation and the EU Pharma legislation.

“In reality, we will not get complete alignment of opinions from every player in the field of pharmaceutical regulatory affairs, but we will get the same interest. We will get the same goals because we are all working towards helping patients get better and better treatments,” said Siegfried Schmitt, vice president, technical at Parexel International and one of the co-chairs of the 2024 RAPS Euro Convergence Programme Committee.

The conference runs 6-8 May in Berlin, Germany, and will feature session tracks on medical devices, pharmaceuticals, IVDs, regulatory business, and AI/software.

Regulatory meets art
This year’s plenary session, to be held on Monday, 6 May, poses the question, “Regulatory Affairs: Science or Art?” The expert panel of patients, regulators, and industry representatives will discuss how science and art intersect in regulatory decisions for pharmaceuticals, devices, and IVDs. The plenary session will also have an artist on site who will draw regulatory themes in a sand box, which will be projected on a screen for attendees.

Jennifer Neff, principal consultant for Entourage and co-chair of the 2024 RAPS Euro Convergence Programme Committee, said the organizers relied on attendee feedback in deciding to make the plenary session less conventional and more interactive.

This session is especially relevant as the industry examines its own changing roles in the face of artificial intelligence, Schmitt said. “Of course, there is all the science for medicines and medical devices, but it’s also, in a way, an art form being in the regulatory affairs profession,” Schmitt said. He added that it is important for all stakeholders to discuss how AI can be appropriately leveraged by regulatory affairs professionals.

AI, supply chain, regulator interactions
This year’s Euro Convergence includes more interactive programming, Neff said. The 2024 conference features “Solutions Circles,” sessions in which industry experts lead small-group discussions on hot topics.

The program also goes beyond the typical operation and strategic regulatory focus to feature sessions related to market access, including the health technology assessment perspective, said Charlie Mortazavi, associate director in global regulatory affairs at Alexion Pharmaceuticals and a member of the Programme Committee. For instance, on Tuesday 7 May, there is a session examining the patient, regulatory, and health technology assessment (HTA) perspectives on a case study of an orphan drug benefit assessment by the German HTA body.

AI and software have their own track at this year’s conference, looking at the potential future role of AI in regulatory affairs and quality management, as well as how the AI Act aligns with the MDR and challenges to AI-enabled medical device conformity assessments.

Schmitt said the inclusion of more AI content was driven by feedback from regulatory affairs professionals and the tension between excitement over opportunities and concerns about how it would change the profession.

“We wanted to really give this topic enough space so we can really discuss it. It’s not only the industry, it’s also the regulators who are trying to understand what do they want to accept, what would they like to see from industry,” Schmitt said. “We’re coming to the point where we need to talk to each other.”

Kate Stockman, vice president of regulatory affairs for Europe, Middle East and Africa for Kenvue and a member of the Programme Committee, said she was excited about the increased content on the pharma side of the program.

“Within the pharmaceutical environment in Europe, we are going through some significant change with the revision of the pharmaceutical regulation and the whole legal framework around drugs is changing. Separately and in parallel, there are also changes around managing supply chains,” Stockman said.

On Tuesday, 7 May, there will be a session on the new EU Pharma Legislation that will include panelists from both the European Commission and the European Medicines Agency. Later, on Wednesday, 8 May, the program features a session on the supply chain and medicine shortages that will explore how to engage with EU initiatives on improving the supply chain.

Gert Bos, Chief Scientific Officer at Qserve Group and chair of the RAPS Board of Directors, said attendees also have a unique opportunity to interact with regulators on Wednesday, 8 May during a session titled, “Interactions that Matter: Conversations with Health Authorities.” The moderated question and answer session is slated to include panelists from the European Commission, the European Medicines Agency, the Competent Authorities for Medical Devices, and others.

“That’s basically an open chance to ask any question you have to the regulators,” said Bos, who is also a member of the Programme Committee.

Make a plan
This year’s conference is the largest Euro Convergence so far, with nearly 900 attendees expected, Schmitt said. As a result of the increased interest, the Programme Committee expanded the lineup of sessions, with up to five sessions running at time.

“On the one hand, there’s a lot of choice for the participants. But it also means that it is prudent to go through the program up front and plan your participation in the most optimal way for your interests,” Schmitt said.

Bos advised attendees to consider their individual goals when planning their approach to the meeting, whether that is meeting people, learning, or finding a new career opportunity. “Make your own plan and be willing to adjust the plan,” he said.

Resist the urge to attend every possible session, said Alex Laan, head of IVD notified body, BSI Group, and a co-chair of the Programme Committee. He suggested that attendees reserve some time to be able to reflect on what they learn.

Members of the Programme Committee also urged attendees not to miss out on the informal network opportunities that happen in the corridors and during breaks in the meeting. “Don’t be shy,” Neff said. “Regulatory people are always open to talk.”

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